MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-01-14 for DORO? SKULL CLAMP QR3 1001.001 manufactured by Pro Med Instruments Gmbh.
[188183366]
Considering the minor deviation of the device, it is very unlikely that the device has contributed to this event. We suspect, that maybe the pinning technique has been not optimal as described in the instructions manual: "adjust the skull clamp to the width of the patient's head in the manner that the two skull pins in the rocker arm are equidistant from the centerline of the head and the single skull pin at the extension assembly is in line with this centerline. "
Patient Sequence No: 1, Text Type: N, H10
[188183367]
Customer service was contacted on (b)(6) 2019 by the customer. Customer stated, that the patient's head slipped while in the skull clamp during posterior cervical laminectomy for spinal cord tumor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003923584-2019-00029 |
| MDR Report Key | 9585944 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-01-14 |
| Date of Report | 2019-12-18 |
| Date of Event | 2019-12-04 |
| Date Mfgr Received | 2019-12-18 |
| Date Added to Maude | 2020-01-14 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. CHONA DELA CRUZ GARCIA |
| Manufacturer Street | BOETZINGER STR. 38 |
| Manufacturer City | FREIBURG, BADEN-WUERTTEMBERG 79111 |
| Manufacturer Country | GM |
| Manufacturer Postal | 79111 |
| Manufacturer G1 | PRO MED INSTRUMENTS GMBH |
| Manufacturer Street | BOETZINGER STR. 38 |
| Manufacturer City | FREIBURG, 79111 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 79111 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORO? SKULL CLAMP QR3 |
| Generic Name | DORO? SKULL CLAMP QR3 |
| Product Code | HBL |
| Date Received | 2020-01-14 |
| Returned To Mfg | 2019-12-18 |
| Model Number | 1001.001 |
| Catalog Number | 1001.001 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PRO MED INSTRUMENTS GMBH |
| Manufacturer Address | BOETZINGER STR. 38 FREIBURG, 79111 GM 79111 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-14 |