MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2020-03-31 for DORO? SKULL CLAMP RADIOLUCENT 3034-00 manufactured by Pro Med Instruments Gmbh.
[188332055]
Conducted visual and functional test: no deviation was detected that could contribute the reported event. We assume that pinning technique can contribute to slippages. Please see the instruction 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
[188332056]
Customer service was contacted on (b)(6) 2020 by the customer. Customer stated that a on a patient was placed in the radiolucent skull clamp and secured with 60 lbs of pressure per the surgeon. The patient was then moved into the prone position for a posterior cervical procedure. During the case, the surgeon felt the skull clamp "pop" and the patient slid down out of the pins with her upper eye lid resting on the base of the skull clamp. The patient received a red mark on her upper eye lid and some bruising in her scalp at her hair line. No lacerations noted from the skull pins.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003923584-2020-00007 |
| MDR Report Key | 9902073 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-05 |
| Device Manufacturer Date | 2014-03-19 |
| Date Added to Maude | 2020-03-31 |
| 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 | MR. ERASMUS BAUMANN |
| Manufacturer Street | B |
| Manufacturer City | FREIBURG, BADEN W 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DORO? SKULL CLAMP RADIOLUCENT |
| Generic Name | DORO? SKULL CLAMP RADIOLUCENT |
| Product Code | HBL |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-09 |
| Model Number | 3034-00 |
| Catalog Number | 3034-00 |
| 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 | 2020-03-31 |