MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-04-07 for DEPUY ACE TRIPPI-WELLS TONG 1365 manufactured by Depuy Ace Medical Co..
[20521059]
On about 2/1/97, the pt (a 68 y/o male) sustained a c2 fracture, type ii as the result of falling off a ladder while putting out a chimney fire. At the time, a halo with a tong was attached. One month later, 3/1/97, pt reported that the tong assembly came off when he yawned. All four pins had come off the pt's head with the vest riding up. Up until this time, the pt had not complained of pain or discomfort. The tongs were replaced with the same. Pt is at home, doing well, no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020311-1997-00013 |
| MDR Report Key | 83055 |
| Report Source | 07 |
| Date Received | 1997-04-07 |
| Date of Report | 1997-04-04 |
| Date of Event | 1997-03-01 |
| Date Facility Aware | 1997-03-14 |
| Report Date | 1997-04-04 |
| Date Mfgr Received | 1997-03-17 |
| Date Added to Maude | 1997-04-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DEPUY ACE TRIPPI-WELLS TONG |
| Generic Name | EXTERNAL FIXATION-CERVICAL |
| Product Code | HAX |
| Date Received | 1997-04-07 |
| Returned To Mfg | 1997-03-17 |
| Model Number | NA |
| Catalog Number | 1365 |
| Lot Number | F3164 & F3165 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 2 YR |
| Device Eval'ed by Mfgr | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 82408 |
| Manufacturer | DEPUY ACE MEDICAL CO. |
| Manufacturer Address | 2260 EAST EL SEGUNDO BLVD. EL SEGUNDO CA 90245 US |
| Baseline Brand Name | DEPUY ACE TRIPPI-WELLS PINS |
| Baseline Generic Name | POSITIONING PINS |
| Baseline Model No | NA |
| Baseline Catalog No | 1365 |
| Baseline ID | LOT #'S 770 & 7 |
| Baseline Device Family | CERVICAL SPINE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K810193 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1997-04-07 |